Afimkibart

DRUG13 trials

Sponsors

Hoffmann-La Roche, F. Hoffmann La RocheLtd

Conditions

Active Ulcerative ColitisAtopic DermatitisCrohns DiseaseDigestive SystemModerately to Severely Active Crohns DiseaseModerately to Severely Active Ulcerative ColitisRheumatoid Arthritis

Phase 1

An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis

RecruitingNCT07665723

Hoffmann-La RocheActive Ulcerative Colitis

Start: 2026-06-29End: 2030-12-31Target: 25Updated: 2026-09-18

Phase 2

Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease

Active, not recruitingNCT05910528

Hoffmann-La RocheCrohns Disease

Start: 2023-07-24End: 2026-12-31Updated: 2026-09-16

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis

Active, not recruitingNCT06863961

Hoffmann-La RocheAtopic Dermatitis

Start: 2025-04-01End: 2027-01-30Updated: 2026-08-10

A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)

RecruitingNCT07137598

Hoffmann-La RocheRheumatoid Arthritis

Start: 2025-12-05End: 2027-10-02Target: 160Updated: 2026-08-25

A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis

RecruitingNCT07223697

Hoffmann-La RocheAtopic Dermatitis

Start: 2026-01-08End: 2033-03-01Target: 120Updated: 2026-09-04

An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis

RecruitingNCT07620392

Hoffmann-La RocheRheumatoid Arthritis

Start: 2026-06-03End: 2033-07-08Target: 120Updated: 2026-09-18

Phase 3

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

RecruitingNCT06588855

Hoffmann-La RocheModerately to Severely Active Ulcerative Colitis

Start: 2024-12-11End: 2031-01-30Target: 350Updated: 2026-08-05

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Active, not recruitingNCT06589986

Hoffmann-La RocheModerately to Severely Active Ulcerative Colitis

Start: 2024-09-17End: 2031-01-30Target: 400Updated: 2026-09-14

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

RecruitingNCT06819891

Hoffmann-La RocheModerately to Severely Active Crohns Disease

Start: 2025-05-12End: 2033-04-30Target: 425Updated: 2026-08-31

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

RecruitingNCT06819878

Hoffmann-La RocheModerately to Severely Active Crohns Disease

Start: 2025-03-17End: 2033-12-31Target: 600Updated: 2026-09-16

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

RecruitingNCT07158242

Hoffmann-La RocheModerately to Severely Active Ulcerative Colitis

Start: 2026-04-15End: 2031-03-31Target: 100Updated: 2026-09-08

A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

RecruitingNCT07298421

Hoffmann-La RocheModerately to Severely Active Crohns Disease

Start: 2026-08-18End: 2031-05-30Target: 100Updated: 2026-09-08

A PHASE III RANDOMIZED DOUBLE-BLIND MULTI-CENTER TREAT-THROUGH STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF INDUCTION AND MAINTENANCE THERAPY WITH AFIMKIBART (RO7790121) IN CHILDREN AGED 2 - 17 YEARS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Active, not recruitingPACTR202606682376312

F. Hoffmann La RocheLtdDigestive System

Start: 2026-03-31Target: 100Updated: 2026-09-14

Related Papers

P0799 Understanding the clinical trial experience of people living with Inflammatory Bowel Disease (IBD), and identifying unmet needs and key challenges that impact trial participation

Journal of Crohn s and Colitis2026-01-01

TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WITH RO7790121 DEMONSTRATES EARLY CLINICAL RESPONSE AND SYMPTOM IMPROVEMENT – RESULTS FROM THE PHASE 2B TUSCANY-2 TRIAL

Inflammatory Bowel Diseases2025-02-01

DOP061 RO7790121 shows early and rapid symptomatic remission in the treatment of moderately to severely active ulcerative colitis – Findings from the phase IIb TUSCANY-2 trial

Journal of Crohn s and Colitis2025-01-011 citations

OP39 Treatment with RO7790121 induces and maintains histologic and histologic-endoscopic improvement and remission in moderately to severely active ulcerative colitis – Results from TUSCANY-2

Journal of Crohn s and Colitis2025-01-011 citations